Featured Story | By Amirah Al Idrus Pfizer is doubling down on Arvinas. Three years after the duo inked a discovery and development deal, they’re adding commercialization to the mix. Pfizer is forking over $650 million upfront and investing $350 million in Arvinas to develop and commercialize the latter’s protein-degrading breast cancer drug. read more |
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Top Stories By Annalee Armstrong Biogen had two high profile gene therapy failures in the middle of the Aduhelm craze, and now they’re going to pay for it. The company has reported $542 million in impairment charges over the two trial flops during second quarter earnings. read more By Nick Paul Taylor Roche is talking to the FDA about its Alzheimer’s disease drug candidate gantenerumab. CEO Severin Schwan declined to speculate on the outcome of the talks amid reports that it will join Eli Lilly in filing for accelerated approval in Alzheimer’s. read more By Annalee Armstrong Sanofi and Regeneron began their collaboration in chronic obstructive pulmonary disorder with a goal of targeting all patients, but now the data is pointing them towards former smokers. A phase 2a study, published in The Lancet Wednesday, failed overall but showed that the monoclonal antibody itepekimab lowered acute COPD exacerbations in former smokers. read more By Ben Adams There’s been precious little good news for Seres Therapeutics of late, and the woe continues today as it records another trial failure. Shares in the microbiome biotech fell more than 52% to $9.90 in early, premarket trading Thursday morning, from a prior close of $20.73. read more By Kyle LaHucik Marcella Ruddy, M.D., joins the pre-clinical biotech after leading the immunology and inflammation development pipeline at Regeneron as vice president for the global program. Ruddy guided Dupixent through "numerous approvals and initiations of many phase 3" trials across the U.S. and the world, Tectonic said. read more By Nick Paul Taylor Hemab has raised $55 million to advance a pipeline of bispecific and monoclonal antibodies to treat patients with rare bleeding disorders. The series A round equips Hemab to take its lead program to clinical proof of concept while advancing its vision of becoming a hemostasis and thrombosis leader. read more By Kevin Dunleavy Seven states unveiled a $26 billion settlement with Johnson & Johnson and the nation's three largest drug distributors—AmerisourceBergen, Cardinal Health and McKesson—to resolve thousands of opioid lawsuits. read more By Angus Liu Pfizer and its JAK inhibitors are falling deeper down a regulatory rabbit hole the company itself opened up. The FDA has once again pushed back decisions for two Pfizer drugs, Xeljanz and investigational abrocitinib. read more By Andrea Park After more than a year spent devoting much of its attention to developing COVID tests, Abbott saw double-digit sales growth across its entire business in the second quarter of 2021, even without the inclusion of COVID-related earnings. read more By Heather Landi Merck has tapped Evidation to explore whether data collected from smartphone apps and wearables can help to diagnose Alzheimer’s disease at an early stage. The two companies are partnering to research whether sensor data can be used to develop digital measures to accelerate drug development for the disease. read more By Angus Liu An investigational breast cancer drug that Bayer licensed from Systems Oncology has shown strong antitumor responses against both primary and metastatic tumors in mice. The drug targets the anticipatory Unfolded Protein Response (aUPR), which normally protects cancer cells but turns toxic when over-stimulated with the drug. read more Resources Sponsored by: WCG Engage Independent Expert Endpoint Adjudication and Data Monitoring Committees in a strategic manner to identify methods for retrospective and prospective evaluations that may improve competitive advantage and bolster regulatory submissions. Sponsored by: Patheon by Thermo Fisher Scientific Take a closer look at your supply chain to ensure it delivers with speed, efficiency, and quality — all within budget. Sponsored by: Patheon by Thermo Fisher Scientific Choose the right AAV platform for your viral vector-based therapy Sponsored by: Blue Matter Consulting E-book to get newcomers “up to speed” quickly on digital health and digital therapeutics while also addressing key issues important to those already familiar with the topic. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. | 
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